Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 5 days ago
- 1 min read
13/08/2026
US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma (Ref)
OS Therapies announced that the US FDA has granted a Type C Statistical Methods meeting to review 2.5-year overall survival data from the Phase 2b OST-HER2 trial in pulmonary metastatic osteosarcoma. This meeting is scheduled for mid-September 2026
Upcoming Readout: Interim 3-year overall survival data is expected in early September 2026, ahead of the FDA meeting.
Regulatory Pathways: Discussions will address comparator arm selection, RMAT designation, and eligibility for Rolling Review. In parallel, the U.K. MHRA has granted a Scientific Advice Meeting to review OST-HER2’s Conditional Marketing Authorisation Application (CMAA).
Clinical Findings: Survival benefit remained stable between the 2-year and 2.5-year timepoints, reinforcing durability of response
Celltrion announced that CT-P73, tissue factor–targeting ADC for recurrent/metastatic cervical cancer, received FDA fast track designation (Ref)
Other ADCs in pipeline:
CT-P70 (c-MET target) – most advanced, expected to enter phase 1 part 2 in March next year
CT-P71 (Nectin-4 target) – progressing through early clinical evaluation
With this Celltrion’s three antibody-drug conjugate (ADC) candidates CT-P70, CT-P71, and CT-P73, have all received FDA fast track status, enabling accelerated development and review for serious diseases with high unmet need
The company plans close consultation with the FDA during early clinical stages and will decide between in-house development or technology transfer based on each candidate’s clinical performance and marketabilit
Comments